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Chronological Index of : Clinical News

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  • CLINICAL NEWS: Inhalable gene therapy meets Phase II endpoint in CF

    Data published Thursday in The Lancet Respiratory Medicine from a Phase II study of pGM169/GL67A to treat cystic fibrosis showed that the inhalable gene therapy led to a significant benefit in lung function. The U.K. …

    Published on 7/2/2015
  • CLINICAL NEWS: Xenon tumbles after Phase IIb OA miss

    Xenon Pharmaceuticals Inc. (NASDAQ:XENE) fell $2 (17%) to $9.53 after its topical TV-45070 failed in a Phase IIb trial to treat chronic pain in patients with osteoarthritis of the knee. The company said 4% and 8% …

    Published on 7/1/2015
  • CLINICAL NEWS: Roche's ocrelizumab meets Phase III MS endpoints

    Roche (SIX:ROG; OTCQX:RHHBY) said ocrelizumab met the primary endpoints of reducing annualized relapse rates (ARR) in two identically designed Phase III studies, OPERA I and OPERA II, to treat relapsing multiple …

    Published on 6/30/2015
  • CLINICAL NEWS: Sembragiline misses AD endpoint

    Evotec AG (Xetra:EVT) said sembragiline (RG1577; EVT 302) missed the primary endpoint in a Phase IIb trial to treat moderately severe Alzheimer's disease. In the MAyflOwer RoAD study conducted by Evotec partner Roche (…

    Published on 6/30/2015
  • CLINICAL NEWS: CSL reports Phase III rIX-FP data

    The CSL Behring subsidiary of CSL Ltd. (ASX:CSL) said three open-label Phase III trials of Factor IX-albumin fusion protein (rIX-FP) to treat hemophilia B met their primary endpoints. Data were presented at the …

    Published on 6/25/2015
  • CLINICAL NEWS: Alcobra dips on Fragile X data

    Alcobra Ltd. (NASDAQ:ADHD) lost $1.09 (13%) to $7.30 on Wednesday after it said metadoxine ER missed the primary endpoint in a Phase II trial to treat Fragile X syndrome. The study showed no statistically significant …

    Published on 6/24/2015
  • CLINICAL NEWS: Transition falls after missing AD endpoint

    Transition Therapeutics Inc. (TSX:TTH; NASDAQ:TTHI) plunged C$7.99 (73%) to C$2.92 in Toronto and fell $6.74 (74%) to $2.35 on NASDAQ on Wednesday after scyllo-inositol (ELND005) missed the primary endpoint in a Phase …

    Published on 6/24/2015
  • CLINICAL NEWS: Boehringer's idarucizumab meets in Phase III

    Boehringer Ingelheim GmbH (Ingelheim, Germany) reported interim data from the Phase III RE-VERSE AD trial of idarucizumab to reverse the anticoagulant effects of Pradaxa dabigatran etexilate in patients who have …

    Published on 6/22/2015
  • CLINICAL NEWS: Epizyme gains on tazemetostat data

    Epizyme Inc. (NASDAQ:EPZM) jumped $5.23 (25%) to $25.98 on Monday after it reported data from an ongoing Phase I dose-escalation study of cancer compound tazemetostat (EPZ-6438) that showed objective responses in blood …

    Published on 6/22/2015
  • CLINICAL NEWS: Tekmira falls on Ebola data

    Tekmira Pharmaceuticals Corp. (NASDAQ:TKMR) lost $1.74 (12%) to $13.28 on Friday on news its TKM-Ebola-Guinea was unlikely to show a therapeutic effect in the Phase II RAPIDE trial to treat Ebola virus infection. As a …

    Published on 6/19/2015
  • CLINICAL NEWS: BioMarin shares spike on dwarfism data

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) gained $15.06 (12%) to an all-time high closing price of $138.66 on Thursday after it reported results post-market Wednesday from a Phase II study of vosoritide (BMN 111) to …

    Published on 6/18/2015
  • CLINICAL NEWS: Radius preparing NDA, MAA for osteoporosis treatment

    Radius Health Inc. (NASDAQ:RDUS) gained $7.91 (15%) to $59.64 after it released six-month top-line data from the ACTIVExtend extension study and from a combined analysis of ACTIVExtend and the Phase III ACTIVE study of …

    Published on 6/18/2015
  • CLINICAL NEWS: Synergy soars on Phase III constipation data

    Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) jumped $3.14 (68%) to $7.78 after two doses of plecanatide met the primary endpoint of improving the proportion of durable overall responders vs. placebo in a Phase III trial …

    Published on 6/17/2015
  • CLINICAL NEWS: Aerie rebounds after FDA clears IOP endpoint

    Aerie Pharmaceuticals Inc. (NASDAQ:AERI) gained $6.64 (50%) to $19.91 on Tuesday after it said FDA will allow the company to change the primary endpoint of the Phase III Rocket 2 trial of glaucoma treatment Rhopressa (…

    Published on 6/16/2015
  • CLINICAL NEWS: Steep descent for Avalanche after AMD data

    Avalanche Biotechnologies Inc. (NASDAQ:AAVL) lost $21.83 (56%) to $17.05 on Tuesday, touching a 52-week low of $17.01 after it released top-line data from a Phase IIa study of its AVA-101 gene therapy to treat wet age-…

    Published on 6/16/2015
  • CLINICAL NEWS: Teva's Austedo meets in Phase III tardive dyskinesia study

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said Austedo deutetrabenazine (SD-809) met the primary endpoint in the Phase III ARM-TD trial to treat moderate to severe tardive dyskinesia. Austedo led to an improvement…

    Published on 6/16/2015
  • CLINICAL NEWS: UCB's Neupro meets in Chinese Phase III PD trial

    UCB Group (Euronext:UCB) reported detailed data from a Phase III trial of Neupro rotigotine in Chinese patients with early stage Parkinson's disease (PD). The company announced top-line results in February. UCB plans to…

    Published on 6/16/2015
  • CLINICAL NEWS: bluebird updates LentiGlobin sickle cell data

    bluebird bio Inc. (NASDAQ:BLUE) said a sickle cell disease (SCD) patient treated with LentiGlobin BB305 gene therapy has remained transfusion independent for three months since receiving his last transfusion 88 days …

    Published on 6/15/2015
  • CLINICAL NEWS: Oncopeptides' melflufen shows similar efficacy to new MM therapies

    Data presented at the European Hematology Association meeting showed that melflufen from Oncopeptides AB (Stockholm, Sweden) could have similar efficacy to other clinical candidates in heavily pre-treated multiple …

    Published on 6/15/2015
  • CLINICAL NEWS: RedHill's antibiotic meets Phase III endpoint

    RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) gained $2.61 (16%) to $19.07 after it said RHB-105 met the primary endpoint of superiority over historical standard of care in the Phase III ERADICATE Hp study to …

    Published on 6/15/2015
  • CLINICAL NEWS: Sunesis reports subgroup data for Qinprezo

    Sunesis Pharmaceutics Inc. (NASDAQ:SNSS) gained $0.08 to $2.62 on Friday after announcing results from a predefined subgroup analysis of its 711-patient Phase III VALOR study of Qinprezo vosaroxin to treat acute …

    Published on 6/12/2015
  • CLINICAL NEWS: FDA panel backs GSK's Bosatria to treat asthma in adults

    FDA's Pulmonary-Allergy Drugs Advisory Committee voted 14-0 that efficacy and safety data support approval of Bosatria mepolizumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat severe asthma with eosinophilic …

    Published on 6/11/2015
  • CLINICAL NEWS: Merck, Samsung biosimilars demonstrate equivalence in RA

    Merck & Co. Inc. (NYSE:MRK) and partner Samsung Bioepis Co. Ltd. said their biosimilars of Enbrel etanercept and Remicade infliximab met the primary endpoint of equivalence to their reference products in separate head-…

    Published on 6/10/2015
  • CLINICAL NEWS: Merck reports data from Januvia CVOT

    Merck & Co. Inc. (NYSE:MRK) reported results from the TECOS cardiovascular outcomes trial (CVOT) of Januvia sitagliptin, which Merck had previously said met the study's primary endpoint of non-inferiority vs. placebo in…

    Published on 6/9/2015
  • CLINICAL NEWS: NIH's RAC wants delayed bluebird trial

    bluebird bio Inc. (NASDAQ:BLUE) sank $11.58 to $175.05 in early after-hours trading Tuesday following postmarket news that NIH's Recombinant DNA Advisory Committee wants the company to delay a pediatric trial of gene …

    Published on 6/9/2015

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